DJO SURGICAL 497-36-000Recalls & reported problems
Encore Medical, L.P. · HEAD, FEMORAL, COCR 36MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical hip implant is a metal femoral head used in total hip replacement surgery. The 37 adverse event reports mostly describe hip dislocation or the joint coming apart or feeling unstable after implantation, along with pain, falls and infection, with 37 injuries and no deaths. Most reports led to revision surgery to replace or adjust the hip components. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00888912024051), received between Sep 2, 2015 and Mar 17, 2026 — classified as 37 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated12
- Adverse Event Without Identified Device or Use Problem10
- Appropriate Device Problem Term/Code Not Available8
- Unstable4
- Fracture2
- Disassembly1
- Excessive Cooling1
- Loose or Intermittent Connection1
Patient problems
- No Code Available14
- Joint Dislocation5
- Unspecified Infection4
- Fall3
- Pain3
- Insufficient Information2
- Joint Laxity2
- No Information2
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
THIS PATIENT HAD A TOTAL HIP ON 6/26/2014. THE PATIENT SUSTAINED A FALL YESTERDAY AND DISLOCATED THE HIP. DR. YACOUBIAN WAS NOT ABLE TO DO A CLOSED REDUCTION AND NEEDED TO DO AN OPEN REDUCTION. HE ELECTED TO REMOVED THE 36ID MP8 10 DEG LINER, 36 METAL HEAD AND -3.5 SLEEVE AND REPLACE THEM WITH A MP8 40ID 10 DEGREE LINER, 40 METAL HEAD AND -3.5 SLEEVE.
Patient problems: Joint Dislocation
MAUDE report 24622300 ↗InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION.
Patient problems: Medical device site infection
MAUDE report 15865055 ↗InjuryAug 4, 2022Mechanical Problem
REVISION SURGERY - THE PATIENT WAS COMPLAINING ABOUT DISCOMFORT AND LEG LENGTH. SURGEON SHORTENED HER WITH A NEUTRAL HEAD.
Patient problems: Discomfort
MAUDE report 15165351 ↗InjuryJan 16, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13262911 ↗InjuryDec 6, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD CHRONIC DISLOCATION. REMOVED AND REPLACED THE HEAD, LINER AND SLEEVE.
Patient problems: Joint Dislocation
MAUDE report 12936968 ↗InjurySep 17, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12491973 ↗InjuryJul 19, 2021Device Dislodged or Dislocated
REVISION SURGERY - PATIENT DISLOCATED HIP AFTER FALLING. REPLACED ORIGINAL HEAD, LINER AND SLEEVE.
Patient problems: Fall
MAUDE report 12189310 ↗InjuryFeb 25, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 11379860 ↗InjuryJun 19, 2020Fracture; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT DISLOCATED POST-OPERATION AND FRACTURED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10173736 ↗InjuryMar 25, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION. SURGEON WASHED OUT AND EXCHANGED OUT THE HEAD.
Patient problems: Unspecified Infection
MAUDE report 9878910 ↗InjuryDec 3, 2019Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS UNSTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9401894 ↗InjuryNov 14, 2019Device Dislodged or Dislocated
InjuryAug 1, 2019Device Dislodged or Dislocated
REVISION SURGERY, HIP DISLOCATED. REMOVED AND REPLACED THE HEAD, SLEEVE AND LINER.
Patient problems: Failure of Implant
MAUDE report 8851259 ↗InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING INFECTION IN HIP; THE SURGEON REMOVED AND REPLACED ALL IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 8671942 ↗InjuryJan 10, 2019Device Dislodged or Dislocated
InjuryAug 24, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF GENERAL LATERAL THIGH PAIN NEAR GREATER TROCHANTER. ACCORDING TO THE REVISION SURGERY IT APPEARED THE ORIGINAL FEMORAL STEM WAS IMPLANTED IN "VARUS" WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR TO PAIN. THE ORIGINAL STEM, HEAD AND LINER WERE REMOVED AND REPLACED.
Patient problems: No Code Available; Pain
MAUDE report 7814546 ↗InjuryFeb 23, 2018Excessive Cooling
REVISION SURGERY - DUE TO CHRONIC DISLOCATION.
Patient problems: No Code Available
MAUDE report 7292321 ↗InjuryOct 27, 2017Device Dislodged or Dislocated
InjuryOct 3, 2017Device Dislodged or Dislocated
InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT PRESENTING AT THE DOCTOR 'S OFFICE WITH PAIN IN HIP. THE REVISION SURGERY WAS SCHEDULED TO PERFORM A HEAD AND LINER EXCHANGE WITH WASH OUT FOR POSSIBLE INFECTION. THE STEM AND HEAD WERE DJO PRODUCTS THE CUP AND LINER WERE MAKO. ONLY A REPLACEMENT HEAD WAS REMOVED AND REPLACED WITH DJO SURGICAL.
Patient problems: Pain
MAUDE report 6888538 ↗InjurySep 13, 2017Device Dislodged or Dislocated
SECOND REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 6861927 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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